This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
129
5 mg Tablet, oral Daily for 12 weeks
10 mg Tablet, oral Daily for 12 weeks
25 mg Tablet, oral Daily for 12 weeks
Percent change from baseline in uterine volume and volume of the largest fibroid.
Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Time frame: Day 1 to 1st post treatment menses
Change from baseline in uterine size in gestational weeks.
Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
Time frame: Week 12 and final visit
Percentage of days with bleeding.
Time frame: Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.
Time frame: Baseline to each visit
Uterine fibroid symptom improvement.
Time frame: Baseline to each visit
Response to Global Efficacy Question regarding improvement in fibroid symptoms.
Time frame: Week 12 and Final Visit
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Tablet, oral Daily for 12 weeks